MAUDE Adverse Event Report: TORAX MEDICAL, INC. 1.5T LINX, 15B; ANTI-REFLUX IMPLANT

Model Number LXMC15

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Scarring (2061); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 8/18/2020.Date of event: unknown, assumed 1st of month that complaint was reported.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: when it is stated in the file: ¿the last time he did a scope on me that i only had one more stretch in me¿.Is this in reference to a dilation procedure? how many dilation's have you had? what were the dates of the dilation's? what was the implant date of the linx device? what are the next steps for medical treatment? we would like to obtain the medical records.Could you please obtain your medical records and share those with us?.

Event Description

It was reported that the device is causing her massive scar tissue, nausea and she can¿t eat.The patient stated she¿s ¿probably lost 80 pounds or better¿.Patient want¿s the device taken out.Implant doctor suggested the device be removed.The original reason for implant was a worn-out lower esophageal sphincter and the patient was sick all the time with pretty much the same symptoms as she is having now.No explant date has been set.The patient has visited the er and her gi dr.About six times or more to have the scar tissue scoped and broken up, but the scar tissue comes back ¿two-fold¿.When the scar tissues builds up it doesn¿t let anything down and doesn¿t let anything up, then she gets sick and dehydrated.

Manufacturer Narrative

(b)(4).Date sent: 9/16/2020.As the device was not returned, an analysis investigation could not be performed.The dhr for lot 17188 was reviewed.No ncs, defects, or reworks related to the product complaint were found.

• Brand Name: 1.5T LINX, 15B
• Type of Device: ANTI-REFLUX IMPLANT
• Manufacturer (Section D): TORAX MEDICAL, INC.; 4188 lexington avenue north; shoreview MN
• MDR Report Key: 10442307
• MDR Text Key: 204441441
• Report Number: 3008766073-2020-00125
• Device Sequence Number: 1
• Product Code: LEI
• UDI-Device Identifier: 00855106005356
• UDI-Public: 00855106005356
• Combination Product (y/n): N
• PMA/PMN Number: P100049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2021
• Device Model Number: LXMC15
• Device Catalogue Number: LXMC15
• Device Lot Number: 17188
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 09/14/2020
• Supplement Dates FDA Received: 09/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention